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FDA Releases Inspection Form 483 for SanGar Plant

Another day brings more bad news for still-closed SanGar Fresh Cut Produce. This time it was the release of the FDA Form 483 report containing observations of the federal food safety inspectors who were in the San Antonio produce distribution plant from Oct. 14 to 26.

It came out after FDA said its own test results were positive for the Listeria bacteria that has been linked to the deaths of elderly Texans.

SanGar was closed by order of the Texas Department of State Health Services on Oct. 20 under a state law that gives it the power to act when there is an imminent threat to human life.

SanGar will not be able to reopen until after a Nov. 17 Texas administrative hearing. In the meantime, it cannot process food and must manage the recall of all the product shipped from the San Antonio facility since January.

Both Texas and FDA have found the deadly Listeria bacteria on SanGar’s chopped celery and from multiple locations inside the plant.

Texas is investigating a 10-case cluster of Listeria cases that have included five deaths. Seven of those illnesses and at least four deaths were linked to SanGar fresh-cut salary.

SanGar officials say they want to reopen and are working with Texas officials and the FDA toward that goal. Carrie Williams, state health department spokesman, says multiple negative test results on food and environmental surfaces will be required before SanGar can reopen.

From the Form 483 observations listed below, the Texas produce company clearly has its work to do:

Observation 1: Failure to protect against contamination of food and food contact surfaces with microorganisms.

Observation 2: Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, and food-packaging materials.

Observation 3: Employees did not wash hands thoroughly in an adequate hand-washing facility at any time their hands may have become soiled or contaminated.

Observation 4: Personnel with adverse health conditions are not instructed to report to their supervisors.

Observation 5: Failure to clean food-contact surfaces and utensils as frequently as necessary and to protect against contamination of food.

Observation 6: Failure to take apart equipment as necessary for thorough cleaning.

Observation 7: Failure to take effective measures to protect finished food from contamination by raw materials and refuse.

Observation 8: Failure to store raw materials in a manner that protects against contamination.

Observation 9: The design, construction, and use of equipment and utensils fail to preclude the adulteration of food with contaminants.

Observation 10: Failure to maintain equipment, containers, and utensils used to store food in a manner that protects against contamination.

Observation 11: Lack of adequate drainage of areas that may contribute to contamination of food by seepage, food-borne filth, and providing a breeding place for pests.

Observation 12: Failure to hold foods that can support the rapid growth of undesirable microorganisms at a temperature that prevents the food from becoming adulterated.

Observation 13: The plant is not constructed in such a manner as to allow floors and walls to be adequately cleaned and kept clean and kept in good repair.

Observation 14: Plumbing constitutes a source of contamination to food, water supplies, equipment, and utensils.